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Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects

Primary Purpose

Glucose Metabolism Disorders, Health Behavior, Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standardized breakfast A
Standardized breakfast B
Sponsored by
BiomeHub Biotechnology Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders focused on measuring Glycemic response, Precision nutrition, Gut Microbiome, Biomarkers, Sequencing analysis, N-of-1 trials

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: BMI > 18.5 and < 30 Willing to use an intradermal continuous glucose monitoring sensor during the 10-day study Own a mobile phone with NFC technology Willing to provide a fecal swab sample and a stool sample Understanding, agreement, and signing of the approved Informed Consent Form (ICF) by the Ethics Committee (CEP) Exclusion Criteria: Pregnant or lactating women Diagnosis of any gastrointestinal disorder or disease (Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease) Intolerance or allergy to any diet ingredient Autoimmune disorder (Lupus, Type 1 Diabetes, Celiac Disease) or infectious disease Diabetes diagnosis Cancer diagnosis, acute myocardial infarction, or stroke in the last 6 months Use of hypoglycemic medication Use of proton pump inhibitors, immunosuppressants, or antimicrobials in the last 3 months Use of laxative medications in the last 30 days Underwent invasive procedures or surgery in the last 6 months Admission to ICU in the last 2 years Participation in any experimental study or ingestion of any experimental drug within twelve months prior to the start of this study, in accordance with RDC 251/97 Inability to read and understand the informed consent form

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Standardized breakfast A

    Standardized breakfast B

    Arm Description

    Consumption order: Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days.

    Consumption order: Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days.

    Outcomes

    Primary Outcome Measures

    Fasting subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)
    All participants will measure fasting subcutaneous interstitial fluid glucose before breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.
    Postprandial subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)
    All participants will measure postprandial subcutaneous interstitial fluid glucose two hours after breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.

    Secondary Outcome Measures

    Participant's gut microbiome species richness
    Gut microbiome profile will be performed by 16S sequencing from participant's fecal sample.

    Full Information

    First Posted
    September 12, 2023
    Last Updated
    October 9, 2023
    Sponsor
    BiomeHub Biotechnology Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06051318
    Brief Title
    Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects
    Official Title
    Individual Effect of Diet on Postprandial Glycemic Response and Its Relationship With Gut Microbiome Profile in Healthy Subjects: Protocol for a Series of Randomized N-of-1 Trials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BiomeHub Biotechnology Company

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    When all the food we eat is digested, it will increase blood glucose. Two people can have different glucose blood levels to the same food and one reason can be bacteria live in our gut. There are more than a thousand bacteria species in our gastrointestinal tract that have an important role in the proper functioning of our body, so our gut microbiome is a key piece for our nutrition and blood glucose control. Nowadays, one of the major public health concerns is the rise of people with diabetes (a disease characterized by an increase in blood glucose) and the increase in obesity, in which one of several risks is diabetes. There are multiple reasons for people develop those diseases, however, some care on diet management can prevent, delay, or improve the effects of these illnesses. Therefore, this study proposes studying the blood glucose variation between healthy volunteers and if there is a relationship between that variation and the intestinal bacteria present. These results can help doctors and nutritionists elaborate a personalized diet for people who need blood glucose level control. The investigators are recruiting volunteers aged 18 to 60, healthy, living at Florianópolis and the surroundings to participate in this crossover randomized N-of-1 study. The participants must collect fecal samples. After collection, the participants will meet the investigators and receive a kit containing ten standardized breakfasts, with two kinds of muffins, and a kit containing a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. The volunteers must have breakfast with the standardized meals and monitor the fasting glucose blood and postprandial glucose blood levels (two hours after the breakfast ingestion) for ten consecutive days. Besides, they must take notes (like a diet diary) about all the food they ingest during the day in ten days of the study.
    Detailed Description
    Choice of design: The study is a N-of-1 randomized series trial with multiple crossovers. Study population: This study will monitor healthy volunteers and they will be recruited via social media like Facebook, Instagram, and LinkedIn platforms. Screening Assessment: The participants will be selected based on inclusion and exclusion criteria by study management researchers. Recruitment will be done via e-mail the participant will receive all the information about the study including the consent term and the anthropometric questionnaire. If he/she accepts it will be sent a collection kit for the fecal samples to the participant's address. Study duration: Each participant will take part in the study for ten days. Dietary intervention: The participants will receive 10 standardized meals, divided into two kinds of muffins, which consist of a low-carbohydrate diet and a vegan one. The low-carb muffin will have a glycemic control characteristic, with a low carbohydrate content, below 45% of the carbohydrates recommended by the Acceptable Macronutrient Distribution Ranges (AMDR), while the vegan muffin will consist entirely of plant-based foods in the recommended macronutrient proportions. Both muffins will be similar in calories and standardized at 25% of daily calories, equivalent to the caloric distribution of breakfast. After the fecal collection, the participant must introduce the standardized meals and the glucose monitoring device inserted. The meal order must obey the randomization established. Before breakfast, the participant will have to measure the fasting glucose with the monitoring glucose device and then eat the breakfast. After two hours, the postprandial glucose must be measured. Participants are free to eat whatever they wish at all other times, but they will report every meal in a diet diary. Together with breakfast, they can drink coffee without milk and sugar or water. The volunteers shouldn't do fasting exercises either for about two hours after breakfast. Anthropometry dietary and lifestyle questionnaire: Before the participants initiate the intervention they will answer a simple questionnaire about their weight, height, gastrointestinal symptoms, stool shape, drugs in use, antibiotics, proton pump inhibitors use, any diagnosis of chronic disease, kind of diet, and activity information. Digital devices: Participants will be asked to record daily dietary intake on an online platform, like Google Sheets. The continuous glucose monitor (Freestyle Libre, CGM) will be inserted on the back of the upper arm by themselves, or if they prefer it can be inserted by one of the researchers when they receive all the study kits. Subcutaneous interstitial fluid glucose will be measured before breakfast and two hours later. At the end of the intervention period, the CGM can be removed at home. Researchers' email addresses and cellphone number will be always available to participants to make any question. Digital app: Participants will need to download the app FreeStyle LibreLink for the subcutaneous interstitial fluid glucose to be measured with their cellphones. Sample size: The sample size was calculated through simulation, assuming a Gaussian multilevel model, comparing two diets with random intercept and diet effects per participant. The simulation assumptions were validated with a nutritionist to ensure plausible values for the outcome, intra-individual and inter-individual outcome variability, and individual effect variability. A minimum clinically significant effect on postprandial blood glucose of 15 mg/dL was determined. This value was used to define the expected range for 95% of true individual effects. The number of cycles was fixed at five to minimize the study time for each recruited participant. Under these assumptions, the simulation of 10,000 series of N-of-1 clinical trials determined it would be recruiting 80 participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glucose Metabolism Disorders, Health Behavior, Diabetes, Metabolic Disease
    Keywords
    Glycemic response, Precision nutrition, Gut Microbiome, Biomarkers, Sequencing analysis, N-of-1 trials

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    The study is a N-of-1 randomized series trial with multiple crossovers.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standardized breakfast A
    Arm Type
    Experimental
    Arm Description
    Consumption order: Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days.
    Arm Title
    Standardized breakfast B
    Arm Type
    Experimental
    Arm Description
    Consumption order: Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days.
    Intervention Type
    Other
    Intervention Name(s)
    Standardized breakfast A
    Intervention Description
    Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days.
    Intervention Type
    Other
    Intervention Name(s)
    Standardized breakfast B
    Intervention Description
    Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days.
    Primary Outcome Measure Information:
    Title
    Fasting subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)
    Description
    All participants will measure fasting subcutaneous interstitial fluid glucose before breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.
    Time Frame
    0 min
    Title
    Postprandial subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)
    Description
    All participants will measure postprandial subcutaneous interstitial fluid glucose two hours after breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.
    Time Frame
    0 min
    Secondary Outcome Measure Information:
    Title
    Participant's gut microbiome species richness
    Description
    Gut microbiome profile will be performed by 16S sequencing from participant's fecal sample.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI > 18.5 and < 30 Willing to use an intradermal continuous glucose monitoring sensor during the 10-day study Own a mobile phone with NFC technology Willing to provide a fecal swab sample and a stool sample Understanding, agreement, and signing of the approved Informed Consent Form (ICF) by the Ethics Committee (CEP) Exclusion Criteria: Pregnant or lactating women Diagnosis of any gastrointestinal disorder or disease (Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease) Intolerance or allergy to any diet ingredient Autoimmune disorder (Lupus, Type 1 Diabetes, Celiac Disease) or infectious disease Diabetes diagnosis Cancer diagnosis, acute myocardial infarction, or stroke in the last 6 months Use of hypoglycemic medication Use of proton pump inhibitors, immunosuppressants, or antimicrobials in the last 3 months Use of laxative medications in the last 30 days Underwent invasive procedures or surgery in the last 6 months Admission to ICU in the last 2 years Participation in any experimental study or ingestion of any experimental drug within twelve months prior to the start of this study, in accordance with RDC 251/97 Inability to read and understand the informed consent form
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luiz Felipe V. de Oliveira, PhD
    Phone
    +554830121322
    Email
    felipe@biome-hub.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Caetana P. Zamparette, PhD
    Organizational Affiliation
    Researcher fellow
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Bianca L. Teixeira, PhD
    Organizational Affiliation
    Clinical research
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Giuliano Netto, Msc
    Organizational Affiliation
    Bioinformatics development and maintenance
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Aline FR Sereia, PhD
    Organizational Affiliation
    Chief Operating Officer
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ana P. Christoff, PhD
    Organizational Affiliation
    Researcher R&D
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Daniela C Bastiani, B.Sc
    Organizational Affiliation
    Laboratory manager
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fernanda RG Piazza, Msc
    Organizational Affiliation
    Nutricionist
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Michele P Rode, PhD
    Organizational Affiliation
    Product Owner
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Milene H Moraes, PhD
    Organizational Affiliation
    Researcher R&D
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Natália M Gutierrez
    Organizational Affiliation
    Laboratory analyst
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We don't have a plan yet.

    Learn more about this trial

    Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects

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